J Dent Educ. 71(8): 1040-1047 2007
© 2007 American Dental Education Association
Development and Interim Results of a Clinical Research Training Fellowship
S.M. Gordon, D.D.S., M.P.H., Ph.D.;
R.A. Dionne, D.D.S., Ph.D.
Key words: translational and clinical research, clinical research training, curriculum, outcomes, educational research
Submitted for publication 01/15/07;
accepted 05/11/07
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Abstract
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While the ability to base clinical training and patient care on scientific evidence is highly dependent on the results of translational and clinical research, a shortage of trained clinical investigators delays advances upon which to base evidence-based therapeutics. In response to this perceived shortage, a clinical research training program was developed in the Division of Intramural Research at the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH) as a prototype for training health professionals in clinical research methodologies and their application to oral-craniofacial problems. All but one of the trainees initiated at least one clinical trial leading to a scientific publication. Of eleven fellows, ten completed the program with diverse outcomes: four trainees have entry-level academic or equivalent research positions; three trainees continued on to Ph.D. programs; one is completing a postdoctoral fellowship combined with clinical specialty training; one is completing a clinical residency; and two are in clinical practice. Six of the trainees received NIH funding, or the equivalent, in the NIH Intramural Research Program. These outcomes suggest that a program focused on translational and clinical research training is a successful strategy for improving the future supply of clinical researchers to support evidence-based practices and therapeutic innovation.
The ability to base clinical training and patient care on scientific evidence is highly dependent on the results of research elucidating mechanisms of health and disease in humans and testing biobehavioral interventions for health promotion and diagnosis and management of diseases and disorders. The overarching goal of this type of research—clinical and translational studies—is to have a significant impact on improving health and preventing disease. For the purpose of this article, "clinical research" refers to all aspects and kinds of clinical research as defined in the Nathan report1 including, for example, epidemiologic and natural history studies, translational research, patient-oriented research, clinical trials, and behavioral studies and outcomes research.
A shortage of trained clinical investigators throughout the health professions2–6 contributes to a paucity of clinical research studies upon which to foster evidence-based therapeutics. There are no data on shortages of clinical investigators in oral health research; however, estimates of self-reported needs from dental schools indicate that faculty shortages impact clinical research capacity.7 Taken together, these observations suggest that the dental profession needs to train more clinical researchers to conduct translational and clinical research and to teach its applications to practice. Increasing opportunities for clinical research training8,9 in a variety of settings will eventually increase the numbers of clinical researchers, raise faculty and student involvement in clinical research, help incorporate evidence into dental education and clinical decision making, and promote science transfer.
While the need and benefit of training more dentists and allied professionals in clinical research are generally accepted and programs have developed curricula over the past five years, few clinical research training programs have developed competencies and identified outcomes that predict academic success, particularly for oral health care professionals. This article describes a clinical research training program that was developed in the Division of Intramural Research at the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health as a prototype for clinical research training focused primarily on dentists. It summarizes the training of a cohort of clinical investigators with diverse backgrounds, and suggests indices for successful transition to an academic career based, in part, on this training.
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Methods: Developing a Clinical Research Training Program Focused on Oral Health
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Traditionally, postdoctoral training has relied primarily on close research mentoring by an experienced investigator, with the assumption that didactic training and research principles have already been assimilated during graduate training. Although this model works well in basic science, it may not be as effective for training the clinical investigator.10 Based on an absence of a strong tradition in clinical research training, a lack of mentors trained in clinical research, and few formalized didactic programs, we combined a traditional postdoctoral research fellowship involving a patient-oriented research project with concurrent didactic training using established academic resources in the NIH environment, as described later. Two multidisciplinary formal training programs in clinical research informed the basis of our program design. These were the NIH-Duke Training Program in Clinical Research11 and the Johns Hopkins Graduate Training Program in Clinical Investigations.
The NIH-Duke Training Program in Clinical Research was developed as a way to tie didactic clinical research training offered through Duke University with a mentored clinical research project conducted in the Intramural Research Program at the NIH. This collaborative program between the NIH Warren G. Magnuson Clinical Center and the Duke University School of Medicine was created in 1998 in response to the Nathan report,1 citing a need for formalized academic training in the quantitative and methodological principles of clinical research. Designed primarily for physicians training for careers in clinical research, the program offers formal courses in research design, research management, and statistical analysis. Academic credit earned by participating in this program may be applied toward satisfying the degree requirement for a master’s of health sciences in clinical research from Duke University School of Medicine. The program is designed to enable part-time study, which allows the fellow/student to integrate the program’s academic training with his or her NIH fellowship experience. Courses for this program are offered by means of videoconferencing from Duke University or on site by adjunct faculty. In addition, students are fellows of the NIH and have access to all institutional resources. Since 1998, 105 students from fifteen NIH institutes and centers have matriculated, and two dentists have completed the program. (For more program details, refer to http://tpcr.mc.duke.edu.)
The Johns Hopkins Graduate Training Program in Clinical Investigations combines curriculum from its School of Medicine and School of Public Health. The program leads to one of two types of master’s degrees or a doctorate degree (Ph.D.) in clinical investigation. (The program is described at www.jhsph.edu/gtpci/programs.html.) As of July 2006, 159 students had entered the program: 113 in the thesis-degree tracks, and forty-six in the master’s of health sciences track. Of these, seventy-six students have completed their degree requirements, fifteen have withdrawn from the program before completion, and sixty-eight are currently in residence or completing their thesis requirement elsewhere. To date, two dentists have been trained through this program.
Design of the Clinical Research Fellowship
Modeling after these two regional clinical research training programs, we sought to integrate the fellowship with the unique resources of the NIH intramural research program. Additionally, we responded to the demand for training arising from clinicians who already held graduate research degrees (master’s or Ph.D.), but were seeking postgraduate research training to supplement their graduate training and prepare them to conduct translational and clinical research. Hence, we developed a Clinical Research Fellowship (CRF) nested in the well-established NIH Division of Intramural Research postdoctoral fellowship program, taking advantage of curriculum offered through the on-site Clinical Center/Duke and nearby Hopkins programs. The first trainees began the program in July 2000, and the last to have completed their fellowships to date did so in June 2005. Since that time, the program has had one to two fellows per year; all are still in the program, and no data for them are included here.
Available resources were adapted to develop a flexible curriculum for trainees of differing backgrounds, varying previous research experience, and diverse future career objectives. The CRF was based on an inter- and multidisciplinary team approach and designed as a one- to three-year, full-time program to train health professionals in the clinical research methodologies and their application to oral-cranio-facial health problems. Clinical research projects were designed to encompass translational research and patient-oriented aspects according to the research interest of the fellows and mentors. Fellows were assigned a research mentor based upon their interests and programmatic needs, and a customized curriculum was developed for each fellow based upon a core clinical research curriculum and specific research interests.
The core didactic curriculum taken by all fellows included epidemiologic and clinical research methods, ethical issues and human subject safety, biostatistics, monitoring patient-oriented research and regulatory issues, preparing and funding a clinical research project, and scientific writing. Trainees could choose electives in areas specific to their research project’s scientific topic, such as immunology, neuroscience, clinical pharmacology, and the like. Educational delivery formats included didactic lectures, small group sessions and projects, and practicum experiences such as a mock institutional review board (IRB) meeting, mock grant review, training in laboratory methods, and case studies. Core curriculum and elective and experiential offerings are listed in Table 1
. (For course details, refer to www.faes.org/graduate_school.htm, http://tpcr.mc.duke.edu/content.asp?page=courses, and www.cc.nih.gov/researchers/training.shtml.)
Fellows applied didactic concepts via supervised experience in experimental methods, protocol development, IRB review, data processing, analysis, and interpretation by initiating and conducting a minimum of one clinical research project under the mentorship of an experienced clinical investigator. Fellows were expected to complete one clinical research project leading to peer-reviewed publication. They were funded to attend one research meeting annually and encouraged to apply for travel awards to increase their participation in research meetings. Trainees who were in the program for three years were also strongly encouraged to submit an NIH career development (K) award application by completion of the second year of their fellowship. Figure 1 illustrates program milestones for trainees.
Outcome Measures as Determinants for Academic Careers in Clinical Research
Outcomes generally considered to be indicative of an independent research career include the following: publications during and following the training and quality of the published research, holding a full-time faculty appointment, being awarded NIH funding, and continued involvement in clinical research.12 We established progress, interim, and long-term outcomes as part of the CRF evaluation plan. Progress outcomes were defined as those accomplished while participating in the program, interim outcomes as those less than five years since program completion, and long-term outcomes as those greater than five years following completion of the program. Progress outcomes included IRB approval and completion of a clinical research protocol, awards and honors, and publications during the fellowship (we did not include funding since NIH fellows cannot control resources). Interim outcomes upon which we base this report include publications arising from research conducted during the fellowship, holding an academic or research position, research funding (federal and other sources), and continued involvement in clinical research. Long-term outcomes are the same as interim, with the addition of teaching and mentoring others in clinical research. We did not evaluate the didactic program, which was drawn from several sources, as those are evaluated by the entity offering them (e.g., Foundation for the Advancement of Education in Science, Duke, NIH Clinical Center, etc.).
Given the small cohort of trainees and the limited time since program completion, we limit our report to descriptive characteristics and interim outcomes. The first five column headings in Table 2 were used as explanatory variables and the last two columns as dependent variables in the analysis. Number of publications was used as either an independent or dependent variable per the analysis. We used descriptive statistics for frequencies and percentages of fellow characteristics. We performed an analysis of factors predictive of continuing in research (defined as obtaining a tenure-track research position or seeking further research training post-program as shown in Table 2 by "Current Position/Teaching") using conditional forward step-wise logistic regression with an alpha level of 0.05. The SPSS statistical software package (v.12.0.2 SPSS Inc., Chicago, IL) was used as the data file and for analysis.
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Results
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Program participants typically held a D.D.S. or D.M.D. and one other advanced degree (M.S. or Ph.D.) or were enrolled in a specialty program. Half of the dentist trainees were licensed to practice dentistry in the United States. All program participants were seeking postdoctoral training focusing on clinical research. Gender distribution was equal; data on age are not available due to federal restrictions, but the majority of fellows were several years out from their clinical doctorate. Of the eleven fellows in the program from July 2000 through June 2005, ten completed the program, earning a certificate for the fellowship, with all completing one to three years of training. More than half of the trainees completed a three-year fellowship; two did a one-year fellowship as part of a combined master’s-endodontic residency program.
Table 2
shows the diverse interim outcomes of program trainees. All the trainees, except the one that did not complete the program, initiated at least one clinical trial leading to publication. Not surprisingly, Table 2 also shows that the number of publications increases with length of the fellowship: those completing a one-year fellowship (half the sample) published one or two papers; of fellows completing three years of research, all but one published more than two papers. Similarly, the number of the clinical studies conducted resulted in more data leading to more publications. Anecdotally, the fellow’s initiative and type of studies conducted also contributed to greater research productivity as measured by number of publications. As might be expected, translational research and clinical studies utilizing biologic samples represented a challenge in mastering laboratory analytic methods, but also provided a greater likelihood of publication because they can generally be completed more quickly than a randomized clinical trial. Among clinical trials, short-term clinical studies were more likely to result in publication than were longer studies or those requiring development of novel laboratory methods. Table 2 also illustrates that those with prior research training (M.S. or Ph.D.) had greater productivity, as measured by publication number, resulting from the studies conducted during the fellowship period.
Three of the trainees who completed three years of the program are in entry-level academic research positions, arguably the strongest outcome indicative of a career in academia.12 Of the remaining trainees with two to three years of training, three subsequently enrolled in Ph.D. programs; one is completing a postdoctoral fellowship combined with a clinical specialty; and one is completing a clinical residency. The two one-year trainees who completed the program as part of their master’s requirement for clinical specialty training did not continue on to any further research training or to academic positions. Interestingly, the one fellow who did not complete the program continued in basic research and also holds an entry faculty position. The reason for not completing the CRF was based on a greater emphasis (and presumed interest) in basic research that was not meeting the program requirements. Analysis of factors predictive of continuing in research (defined as obtaining a tenure-track research position or seeking further research training after the program) showed that prior research training (M.S. or Ph.D.; P=0.007) and duration of CRF training (<2 yr or 
2 yr; P=0.02) were the most significant variables in the model. Specialty status during the time of training did not enter the model (P=0.06), although none of the program participants engaged in specialty training concurrent with the CRF have continued in research to date.
Successful research funding is also considered to be a quantifiable outcome indicative of future academic success and, by implication, of the success of a research training program.12 Fifty-five percent of the fellows obtained research funding after leaving the program. Four of the trainees received NIH career development awards (K08, K22, and K23), and one trainee is a tenure-track candidate in the NIH Intramural Research Program, the equivalent of a career transition award in the NIH intramural research environment. Two of the three K awardees subsequently applied for introductory NIH funding (R03 and R21), and one was awarded (R21). Three trainees were also supported through the NIH Loan Repayment Program (LRP). In addition to NIH funding, we included all funding in Table 2 to encompass other support, such as from professional organizations, foundations, and industry. One fellow (K23 recipient) has such funding. The eventual funding success for the trainees currently enrolled in Ph.D. programs or other training and the research fellow in the NIH Intramural Research Program cannot be assessed at this time.
Another indicator of scholarly contribution is teaching. Four CRF alumni are teaching in dental schools in their respective research areas (Table 2). If the axiom holds true that research informs teaching, then a potential contribution of dentists-scientists to dental education is translating research findings into evidence throughout the curriculum. The two alumni in private practice and four in Ph.D. programs are not currently teaching, nor are the two NIH intramural scientists. Presumably this is circumstantial rather than by choice. Virtually all of the trainees have served as mentors for summer students.
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Discussion
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While long-term outcomes cannot yet be assessed, prognostic factors for academic success suggest that the program produced several trainees likely to pursue clinical research as part of an academic career. Only one of the trainees did not complete the program over a five-year period. The majority of trainees (72.7 percent) remained in research: obtaining a tenure-track position or seeking further research training. Of those trainees, four are conducting translational research and the remainder patient-oriented research. It is unlikely that the two trainees currently in clinical practice will seek or receive NIH funding; however, it remains to be seen whether they eventually seek academic appointments. Although from a small sample, our data are consistent with observations from extramural NIDCR training and career development programs indicating that research training combined with clinical specialty training rarely leads to a productive research career among dentists.12 It should be noted these analyses included only NIDCR-funded trainees using NIH funding as the outcome variable, while we believe that other indices, such as non-NIH sources of funding and publication record, are as appropriate to assess. Success rates from these analyses must be cautiously interpreted due to potential lack of generalizability of the cohort and because NIH funding success varies by grant mechanism, budget in any given fiscal year, and number of resubmitted applications. That said, it is important to note that some physicians who have concurrently engaged in specialty and research training have a better track record using the same NIH analytic criteria. For example, slightly more than half of former recipients of the American Association of Obstetricians and Gynecologists fellowships have successfully competed for NIH research funding at least once, with 22 percent being awarded at least one R01.13
The failure of the two trainees who were enrolled in a combined M.S.-endodontic residency to pursue further research or research training may reflect prior self-selection for a clinical specialty having a mandatory research training component, which may not be reflective of a true interest in an academic career. A survey of Canadian medical anesthesiology residents reported that 75 percent of respondents would prefer to engage in an alternate academic activity rather than completing the mandatory research project that is part of the residency training.14 The respondents viewed the time set aside for research as competing with time spent learning the clinical aspects of the specialty and also that the research time was not sufficiently protected, thus coming at the expense of personal time. A survey of radiology residents also reported that research was an extra time commitment rather than an integral part of the curriculum, and they were less willing to sacrifice personal time for research training.15
Although the current faculty shortage is most acute in clinical specialties,4,5 our interim results suggest that shorter research training experiences such as those typical of specialty training programs incorporating a master’s degree (one year in our program) are less likely than experiences of longer duration (two to three years) to result in continuing towards an academic career. We cannot conclude whether that is due to the nature of the commitment of the trainee or whether one year is insufficient time to build skills, interest, and confidence in clinical research. While it is premature to project long-term outcomes, our interim results suggest that continued research commitment as measured by pursuit of additional research training (research doctoral or postdoctoral training) and seeking funding during their entry faculty appointment after training is an indicator of a future academic research career for most of the two- to three-year trainees. Although two former trainees are currently engaged in clinical specialty training, one undertook a traditional three-year postdoctoral fellowship concurrent with the residency and is seeking an entry faculty position. The other is completing clinical residency with an offer for a faculty position upon completion. The additional time spent in research activity post-fellowship is indicative of a sustained interest in clinical research (Table 2) and may translate into a tenure-track faculty appointment in their specialty areas.
This pilot program preceded development of the NIH Clinical Center’s Clinical Research Curriculum Certificate for intramural postdoctoral fellows.11 Subsequently, the NIH has also initiated extramural awards for clinical research training. Several of these NIH multidisciplinary institutional clinical research (K12) programs have been awarded to universities with participation by dental schools, and the NIDCR has awarded three specifically to dental schools. These institutional programs provide an infrastructure to support clinical research training that includes mentors and projects, patient populations, and salary support and protected time. These combined resources permit trainees to develop their research interests and apply for initial funding to develop towards independent research careers.
Clinical research is a complex endeavor that is ideally performed by a multidisciplinary team using an integrated team approach, involving study coordinators, data managers, clinicians, statisticians, and those who have scientific expertise in the design and oversight of the research. In addition, successful training is highly dependent on the availability of appropriate mentors, both for scientific and clinical research methodology. We were fortunate that the NIH environment provided this expertise and mentorship capabilities, but in the absence of a strong infrastructure for clinical research, this critical component may be difficult to achieve. For that reason, programs should expand their scope beyond dental school walls for mentors who can provide training in multidisciplinary settings. By providing the training experience in a multidisciplinary setting, it is more likely that trainees will be prepared for the real world requirements of clinical research.16
Although our program by environmental necessity was limited to postdoctoral trainees, programs ideally would be designed to provide a flexible and efficient entrée into clinical research for individuals at a variety of educational levels to maximize potential development of knowledge and interest in clinical research. This may be more easily achieved in the educational academic setting than in the NIH intramural program, which is not degree-granting and in which the majority of trainees are at the postdoctoral level. As observed for other research training programs, it is critical to ensure training candidates have a strong motivation for clinical research and towards an academic career, versus viewing the training as a mechanism to gain financial support or as a way to obtain specialty training using the program as a vehicle. Lastly, we recommend interim milestone evaluation for trainees to identify failure to progress. Our experience shows the identification of failure to achieve program progress milestones in a timely fashion and developing an alternative training plan are in the best interest of the trainee’s career development, as well as of the program.
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Conclusion
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The dwindling number of clinician-scientists across the health professions has led to increased efforts to develop clinical research training programs to help facilitate entry to careers in research academia and promote research that will contribute to better understanding of health and disease. We report interim findings for a postdoctoral level clinical research training program focusing on qualitative and quantitative outcomes predictive of developing an independent research career in clinical research focused on oral and craniofacial health. Acknowledging the limitations of interim outcomes and a small cohort, we found that trainees with a strong commitment to research, as evidenced by research experience prior to the fellowship, engaging in a longer training duration tended to continue conducting translational and clinical research post-fellowship. They also published more, sought and obtained funding, and chose faculty positions over private practice. Clinical research training in an environment that promotes protected time for immersion in research training and the conduct of research has the potential to enhance overall scientific knowledge and develop skills to propagate translational and applied research of oral-craniofacial diseases.
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Acknowledgments
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At the time of the development of this program, the authors directed the NIDCR Intramural Research Training Program and the Clinical Research Program, respectively. We gratefully acknowledge the resources and support of the then-director, Dr. Harold Slavkin, and scientific director, Dr. Henning Birkedal-Hansen, who encouraged the development of the program. We also thank the NIH Clinical Center educational programs and the NIH Office of Education for their collaboration, and extend appreciation to the NIDCR senior scientists who served as mentors. This program is supported by the NIDCR, NIH Intramural Research Program. For information on the current program, see www.nidcr.nih.gov/Research/Intramural/ClinicalResearchCore/NIDCRClinicalResearchFellowship.htm.
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Footnotes
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Dr. Gordon is Associate Professor, Department of Biomedical Sciences, University of Maryland Dental School, Baltimore College of Dental Surgery; Dr. Dionne is Scientific Director, National Institute of Nursing Research, National Institutes of Health, Department of Health and Human Services, U.S. Public Health Service. Direct correspondence and requests for reprints to Dr. Sharon M. Gordon, Department of Biomedical Sciences, University of Maryland Dental School, 650 W. Baltimore Street, Room 8209, Baltimore, MD 21231; 410-706-1656 phone; 410-706-0193 fax; sgordon{at}umaryland.edu.
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Abstract
Methods: developing a clinical...
